Article 112: Evaluation and Review
Article 112
Evaluation and Review
Updated on 31 July 2024 based on the version published in the Official Journal of the EU dated 12 July 2024 and entered into force on 1 August 2024.
1. The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period of the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the European Parliament and the Council.
2. By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the EuropeanParliament and to the Council on the following:
- the need for amendments extending existing area headings or adding new area headings in Annex III;
- amendments to the list of AI systems requiring additional transparency measures in Article 50;
- amendments enhancing the effectiveness of the supervision and governance system.
3. By 2 August 2029 and every four years thereafter, the Commission shall submit a report on the evaluation and reviewof this Regulation to the European Parliament and to the Council. The report shall include an assessment with regard to thestructure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis ofthe findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. Thereports shall be made public.
4. The reports referred to in paragraph 2 shall pay specific attention to the following:
- the status of the financial, technical and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation;
- the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for infringements of this Regulation;
- adopted harmonised standards and common specifications developed to support this Regulation;
- the number of undertakings that enter the market after the entry into application of this Regulation, and how many of them are SMEs.
5. By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has beengiven sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the properimplementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and toincrease its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the Council.
6. By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progresson the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, andasses the need for further measures or actions, including binding measures or actions. The report shall be submitted to theEuropean Parliament and to the Council, and it shall be made public.
7. By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness ofvoluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systemsother than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems,including as regards environmental sustainability.
8. For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide the Commission with information upon its request and without undue delay.
9. In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account the positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources.
10. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light of the state of progress in the information society.
11. To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to develop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the relevant Articles and the inclusion of new systems in:
- the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in that Annex;
- the list of prohibited practices set out in Article 5; and
- the list of AI systems requiring additional transparency measures pursuant to Article 50.
12. Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which concerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory specificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and authorities established therein.
13. By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shallreport on it to the European Parliament, the Council and the European Economic and Social Committee, taking intoaccount the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, beaccompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need fora Union agency to resolve any identified shortcomings.
Table of Contents
Chapter III: High-Risk AI Systems
- Section 1: Classification of AI Systems as High-Risk
- Section 2: Requirements for High-Risk AI Systems
- Article 8: Compliance with the Requirements
- Article 9: Risk Management System
- Article 10: Data and Data Governance
- Article 11: Technical Documentation
- Article 12: Record-Keeping
- Article 13: Transparency and Provision of Information to Deployers
- Article 14: Human Oversight
- Article 15: Accuracy, Robustness and Cybersecurity
- Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties
- Article 16: Obligations of Providers of High-Risk AI Systems
- Article 17: Quality Management System
- Article 18: Documentation Keeping
- Article 19: Automatically Generated Logs
- Article 20: Corrective Actions and Duty of Information
- Article 21: Cooperation with Competent Authorities
- Article 22: Authorised Representatives of Providers of High-Risk AI Systems
- Article 23: Obligations of Importers
- Article 23a
- Article 24: Obligations of Distributors
- Article 25: Responsibilities along the AI Value Chain
- Article 26: Obligations of Deployers of High-Risk AI Systems
- Article 27: Fundamental Rights Impact Assessment for High-Risk AI Systems
- Section 4: Notifying Authorities and Notified Bodies
- Article 28: Notifying Authorities
- Article 29: Application of a Conformity Assessment Body for Notification
- Article 30: Notification Procedure
- Article 31: Requirements Relating to Notified Bodies
- Article 32: Presumption of Conformity with Requirements Relating to Notified Bodies
- Article 33: Subsidiaries of Notified Bodies and Subcontracting
- Article 34: Operational Obligations of Notified Bodies
- Article 35: Identification Numbers and Lists of Notified Bodies
- Article 36: Changes to Notifications
- Article 37: Challenge to the Competence of Notified Bodies
- Article 38: Coordination of Notified Bodies
- Article 39: Conformity Assessment Bodies of Third Countries
- Section 5: Standards, Conformity Assessment, Certification, Registration
- Article 40: Harmonised Standards and Standardisation Deliverables
- Article 41: Common Specifications
- Article 42: Presumption of Conformity with Certain Requirements
- Article 43: Conformity Assessment
- Article 44: Certificates
- Article 45: Information Obligations of Notified Bodies
- Article 46: Derogation from Conformity Assessment Procedure
- Article 47: EU Declaration of Conformity
- Article 48: CE Marking
- Article 49: Registration
Chapter V: General-Purpose AI Models
Chapter VI: Measures in Support of Innovation
- Article 57: AI Regulatory Sandboxes
- Article 58: Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
- Article 59: Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
- Article 60: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
- Article 61: Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
- Article 62: Measures for Providers and Deployers, in Particular SMEs, including Start-Ups
- Article 63: Derogations for Specific Operators
Chapter VII: Governance
Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance
- Section 1: Post-Market Monitoring
- Section 2: Sharing of Information on Serious Incidents
- Section 3: Enforcement
- Article 74: Market Surveillance and Control of AI Systems in the Union Market
- Article 75: Mutual Assistance, Market Surveillance and Control of General-Purpose AI Systems
- Article 76: Supervision of Testing in Real World Conditions by Market Surveillance Authorities
- Article 77: Powers of Authorities Protecting Fundamental Rights
- Article 78: Confidentiality
- Article 80: Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
- Article 81: Union Safeguard Procedure
- Article 82: Compliant AI Systems which Present a Risk
- Article 82a
- Article 83: Formal Non-Compliance
- Article 84: Union AI Testing Support Structures
- Article 79: Procedure at National Level for Dealing with AI Systems Presenting a Risk
- Section 4: Remedies
- Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models
- Article 88: Enforcement of the Obligations of Providers of General-Purpose AI Models
- Article 89: Monitoring Actions
- Article 90: Alerts of Systemic Risks by the Scientific Panel
- Article 91: Power to Request Documentation and Information
- Article 92: Power to Conduct Evaluations
- Article 93: Power to Request Measures
- Article 94: Procedural Rights of Economic Operators of the General-Purpose AI Model
Chapter XIII: Final Provisions
- Article 102: Amendment to Regulation (EC) No 300/2008
- Article 103: Amendment to Regulation (EU) No 167/2013
- Article 104: Amendment to Regulation (EU) No 168/2013
- Article 105: Amendment to Directive 2014/90/EU
- Article 106: Amendment to Directive (EU) 2016/797
- Article 107: Amendment to Regulation (EU) 2018/858
- Article 108: Amendment to Regulation (EU) 2018/1139
- Article 109: Amendment to Regulation (EU) 2019/2144
- Article 110: Amendment to Directive (EU) 2020/1828
- Article 111: AI Systems Already Placed on the Market or Put into Service and General-Purpose AI Models Already Placed on the Marked
- Article 112: Evaluation and Review
- Article 113: Entry into Force and Application